Immunogenicity Testing Services

Ligand-binding assays (LBA) are central to immunogenicity testing, enabling sensitive detection and quantitation of ADAs, neutralizing activity, and soluble immune mediators. They provide key insights into immune responses, including cytokine release and humoral antibody activity, without requiring live cells.

Cell-based assays use living cells to evaluate the functional impact of ADAs on a therapeutic’s activity. In NAb testing, these assays measure an antibody’s ability to neutralize the drug’s effect on its cellular target, making them particularly important when the drug interacts with receptors that trigger cellular responses.

ELISpot allows sensitive quantification of antigen-specific cells by measuring their ability to secrete cytokines or other soluble mediators, offering a robust readout of immune activation.

Flow cytometry enables multiparametric characterization of antigen-reactive cells, providing information on cell type, differentiation, activation status, and functional responses such as proliferation, cytokine production, and cytotoxic activity.

Acid Dissociation improves drug tolerance by breaking drug–antibody complexes, allowing ADAs to be detected in the assay. At KCAS Bio, we often include MgCl₂ to enhance the dissociation of immune complexes.

Discover our work on Acid Dissociation in this poster

Affinity Capture and Elution (ACE) enhances drug tolerance by dissociating ADA–therapeutic complexes, capturing ADAs on an immobilized drug, and transferring them to a bridging assay for sensitive detection.

Solid Phase Extraction & Acid Dissociation (SPEAD) reduces drug interference by dissociating ADA–therapeutic complexes, capturing ADAs on a plate, and transferring them to a bridging assay for sensitive detection.

Statistical Support for Cut-Point Determination ensures accurate interpretation of immunogenicity data by defining the threshold between positive and negative ADA responses. Using expert tools like Red Thread™, KCAS Bio streamlines this complex process, enabling reliable, guideline-compliant cut-points that are critical for assessing safety, efficacy, and immune response risk.

Yes. KCAS Bio provides non-GLP exploratory testing for early discovery and assay development, as well as GLP-compliant studies for pivotal preclinical toxicology and clinical sample analysis, ensuring data integrity and regulatory readiness across all phases.

Yes, we measure antibody and T-cell responses to evaluate the magnitude and quality of immune responses in preclinical and clinical studies

Absolutely. We monitor immune responses to vectors, transgenes, and therapeutic proteins across all development phases using tailored cell-based and plate-based assays.

Clinical ADA assays use drug-specific critical reagents and a three-tiered approach (screening, confirmation, titration) to ensure regulatory compliance. Preclinical ADA assays are more flexible and are guided by ICH S6, evaluating ADAs when there are altered pharmacodynamics, unexpected exposure changes, or immune-mediated reactions.

While conventional ADA assays follow a three-tier structure, “lean ADA assays” are often more suited for the preclinical and nonclinical phases. These assays typically require only two of the three tiers, such as screening and titer, or screening and confirmation, depending on the specific drug being tested. Additionally, when a positive control hasn’t been developed, a commercially available polyclonal antibody can often be used, further simplifying the process.

Cell-based NAb assays closely mimic in vivo conditions, providing biologically relevant results and higher sensitivity to detect subtle neutralizing antibody effects that non-cell-based assays might miss.

Non-cell-based assays are reliable for many biologics, especially those targeting humoral components. However, for drugs that act on cellular receptors, have complex mechanisms, or require physiological relevance, cell-based assays are preferred to fully assess neutralizing activity.

Development time varies with assay complexity and the biologic’s characteristics. Simple non-cell-based assays can be ready in a few months, while complex cell-based assays may take 6–12 months or longer to optimize and validate under regulatory requirements.